Salivary Flow, pH, and Buffering Capacity in Fixed and Clear Aligner Orthodontic Treatment
Starting soon · Not applicable
Conditions studied: Orthodontic Treatment, Saliva
In brief
Study Design: A randomized controlled trial with two parallel arms and an allocation ratio of 1:1. Setting: The study will be conducted in the orthodontic department of Riyadh Elm University hospitals in Riyadh City, Saudi Arabia. Participants: Patients undergoing fixed or clear aligner orthodontic treatment referred to REU dental hospital will be randomly allocated to either the clear aligner group or the fixed orthodontic appliance group. Intervention: Prior to orthodontic treatment, all patients will receive phase I periodontal therapy and oral hygiene instructions. Fixed orthodontic appliances will be bonded using metallic brackets with a 0.022-inch slot and 0.014-inch NiTi archwires. Clear aligner patients will receive Invisalign® treatment. Outcomes and Saliva Collection: Salivary samples will be collected using the spitting method at baseline (T0) and follow-up time points according to the study protocol. Salivary flow rate, pH, and buffering capacity will be assessed as described in the proposal. Randomization and Blinding: Randomization will be performed using a random number generator with allocation concealment via opaque envelopes. The investigators involved in outcome assessment and data analysis will be blinded. Ethical Considerations: The study will be submitted to the Institutional Review Board at Riyadh Elm University and conducted in accordance with IRB policies.
Key facts
- Study ID
- NCT07397871
- Run by
- Riyadh Elm University
- People needed
- 40
- Starts
- 2026-03-15
- Expected to finish
- 2027-05-29
- Last updated by the study team
- 2026-02-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Class I, II and III skeletal malocclusion.
- Age ≥18 undergoing fixed or Clear aligner orthodontic treatment.
You may not qualify if…
- Current medications including antibiotic use within the past 3 months that affect salivary flow and composition.
- Active smoking including vaping and E-cigarette use.
- Diagnosis of systemic diseases/conditions such as Sjogren's syndrome, diabetes, chronic kidney diseases, neurological conditions.
- Active dental caries or signs of gingivitis and/or periodontitis
- Less than three months of orthodontic treatment since it is characterized by acute, temporary changes and patient adaptation to the new appliances.
- Requiring single arch treatment to standardize the research and eliminate a potential confounding variable
- Crown restoration is excluded due to their material properties which may affect salivary composition.
- Pregnancy due to the physiological variation in salivary flow and composition due to hormonal changes.
- Presence of mouth breathing may lead to inconsistent salivary flow rate, Changes in Salivary Composition and pH
- Poor oral hygiene with high levels of dental plaque, calculus, and gingival inflammation can independently alter salivary flow rate, pH, and buffer capacity there by acting as confounding variable.
Where it is running
- Riyadh Elm University — Riyadh, Saudi Arabia
Full record on ClinicalTrials.gov
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